Fingerprint test pad and method for fingerprinting using particle based immunoassay

• US 5,244,815 A
• Filed: 09/13/1991
• Issued: 09/14/1993
• Est. Priority Date: 01/19/1990
• Status: Expired due to Term

• Current Assignee: La MINA Limited
• Original Assignee: Lamina, Inc. (The Anchor Danly Group)
• Inventors: Guirguis, Raouf A.
• Primary Examiner(s): Kepplinger, Esther L.
• Assistant Examiner(s): Bidwell, Carol E.
• Application Number:
  US07/759,922
• Time in Patent Office: 732 Days
• Field of Search: 436/530, 436/531, 436/518, 436/534, 436/525, 436/536, 436/810, 436/815, 436/816, 436/901, 436/538, 436/808, 422/56, 422/57, 422/60, 435/975, 435/7.92
• US Class Current: 436/530
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 2010/0009 Testing for drug or alcohol abuse
• CPC Class Codes: A61B 5/1172 using fingerprinting
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/94 involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
• CPC Class Codes: Y10S 436/80 Fluorescent dyes, e.g. rhodamine
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/815 Test for named compound or class of compounds
• CPC Class Codes: Y10S 436/816 Alkaloids, amphetamines, and barbiturates
• CPC Class Codes: Y10S 436/817 Steroids or hormones
• CPC Class Codes: Y10S 436/901 Drugs of abuse, e.g. narcotics, amphetamine

Abstract

A method and device for testing for the presence of substances such as drugs in body fluids while simultaneously positively identifying the test subject. The device comprises an absorbent pad and a membrane mounted to the absorbent pad containing a plurality of separated areas provided with different immobilized ligand having a specific receptor site for capture or rejection of specific antigens produced by different predetermined drugs. The method of testing comprises the steps of: (a) obtaining a quantity of body fluid in a container, (b) adding an antibody to the body fluid to form a mixed solution, (c) placing the mixed solution on a membrane and absorbent pad device and immobilized ligands, (d) covering the finger with a thin film of labelled antibody and (e) placing the finger on the membrane containing immobilized ligand specifically selected to bind to labelled antibody presenting the fingerprint of the test subject, the presence or absense of substances being tested for in the body fluid so that solution is deposited from the finger on the membrane indicating presence or absence of the substance.

Claims

1. A method for testing for analytes in a body fluid of a test subject and positively identifying said test subject by producing a fingerprint of said test subject comprising the steps of:

(a) obtaining a quantity of body fluid from said test subject;

(b) combining anti-analyte antibodies which specifically bind to said analytes with said body fluid to form a solution whereby said anti-analyte antibodies specifically bind to said analytes if present therein;

(c) applying said solution to the membrane of a test device, said membrane comprising a control zone for recording a fingerprint of said test subject, said control zone having anti-species antibody immobilized thereon that specifically binds labelled antibody added as the detection antibody and test zones for determining the presence of said analytes, said test zones having antigens immobilized thereon that specifically bind to said anti-analyte antibodies wherein said solution contacts said control and test zones and wherein said anti-analyte antibodies not bound in step (b) bind to said antigens immobilized in said test zones;

(d) coating a finger of said test subject with labelled antibody which specifically binds to said anti-analyte antibodies and said anti-species antibody; and

(e) placing the coated finger onto said membrane of said test device thereby contacting said control and test zones wherein a fingerprint of said test subject is produced in said control area and wherein said labelled antibody binds to said anti-analyte antibodies bound in said test areas, the presence of said labeled antibody indicating the absence of said analytes in said body fluid and the absence of said labeled antibody indicating the presence of said analytes in said body fluid.

2. The method of claim 1 wherein said antigens are immobilized as antigen coated particles.

3. The method of claim 1 wherein said labelled antibody is labelled with colloidal gold.

4. The method of claim 1 wherein said labelled antibody is labelled with a fluorescent label.

5. The method of claim 1 wherein said anti-analyte antibodies are mouse anti-analyte antibodies.

6. The method of claim 1 wherein said labelled antibody is labelled goat anti-mouse antibody.

7. The method of claim 1 wherein said body fluid is saliva.

8. The method of claim 1 wherein said body fluid is blood.

9. The method of claim 1 wherein said body fluid is urine.

10. The method of claim 1 wherein said anti-species antibody is mouse anti-goat antibody.

11. A method as claimed in claim 1 wherein said analyte is a drug.

12. A method as claimed in claim 1 wherein said analyte is cocaine.

13. A method as claimed in claim 1 wherein said analyte is PCP.

14. A method as claimed in claim 1 wherein said analyte is THC.

15. A method as claimed in claim 1 wherein said analyte is methamphetamine.

16. A method as claimed in claim 1 wherein said analyte is alcohol.

17. A method as claimed in claim 1 wherein said analyte is opiate.

18. A method for testing for drugs or metabolites thereof in a human body fluid and simultaneously positively identifying the test subject from whom said body fluid is collected by producing a fingerprint of said test subject comprising the steps of:

(a) mixing said body fluid collected from said test subject with anti-drug or anti-drug metabolite antibodies specific for said drugs or said metabolites thereof to form a composite solution wherein said anti-drug or anti-drug metabolite antibodies specifically bind to said drugs or said metabolites thereof respectively if present in said body fluid;

(b) covering the surface of a membrane of a test device with said composite solution, said surface of said membrane comprising a control zone for recording said fingerprint of said test subject, said control zone having immobilized thereon anti-species antibody that specifically binds labelled antibody added as the detection antibody and test zones for determining the presence of said drugs or metabolites thereof, said test zones having immobilized thereon antigens that specifically bind to said anti-drug or anti-drug metabolite antibodies;

(c) allowing said solution to incubate on said surface of said membrane for a specific period of time so that said anti-drug or anti-drug metabolite antibodies not bound in step (a) bind to said antigens immobilized in said test zones;

(d) coating a portion of a finger of said test subject with labelled antibody which specifically binds to said anti-drug or anti-drug metabolite antibodies and said anti-species antibody; and

(e) pressing said finger against said control and test zones on said surface of said membrane to deposit said labelled antibody onto said surface wherein a fingerprint is produced in said control zone and wherein said labelled antibody binds to said anti-drug or anti-metabolite antibodies bound in said test zones, the presence of said labeled antibody in said test zones indicating the absence of said drugs of metabolites thereof in said body fluid and the absence of said labeled antibody in said test zones indicating the presence of said drug or metabolic breakdown product thereof in said body fluid.

19. The method of claim 18 wherein said drug are selected from the group consisting of opiates, barbiturates, antipsychotics, antidepressants, analgesics, sedatives, hypnotics, benzodiazepines, solvents, stimulants, hallucinogens and anabolic steroids.

20. The method of claim 18 wherein said composite solution incubated in step (c) is incubated for at least two minutes.

21. The method of claim 18 wherein said composite solution incubated in step (c) is incubated for one to three minutes.

22. The method of claim 18 wherein said finger is pressed against said membrane surface for about 5 seconds.

23. The method of claim 18 wherein said labelled antibody is labelled with colloidal gold.

24. The method of claim 18 wherein the label of said labelled antibody comprises gold particles coated with silver.

25. The method of claim 18 wherein said anti-drug or anti-drug metabolite antibodies are mouse anti-drug or mouse anti-drug metabolite antibodies.

26. The method of claim 18 wherein said labelled antibody is labelled goat anti-mouse antibody.

27. The method of claim 18 wherein said body fluid is saliva.

28. The method of claim 18 wherein said body fluid is blood.

29. The method of claim 18 wherein said body fluid is urine.

30. The method of claim 18 wherein said anti-species antibody is mouse anti-goat antibody.

31. The method of claim 18 further comprising washing said membrane surface after step (c).

32. A method of testing for drugs or metabolites thereof in a body fluid of a test subject and also positively identifying said test subject from whom said body fluid is collected by producing a fingerprint of said test subject comprising the steps of:

(a) mixing said body fluid taken from said test subject with anti-drug or anti-drug metabolite antibodies specific for said drugs or metabolites thereof respectively to form a composite solution wherein said anti-drug or anti-drug metabolite antibodies specifically bind to said drugs or metabolites thereof respectively if present in said body fluid;

(b) covering the surface of a membrane of a pad assembly, such pad assembly comprising said membrane mounted on an absorbent pad, with said composite solution, said surface comprising a control zone for recording said fingerprint of said test subject, said control zone having anti-species antibody immobilized thereon that specifically binds labelled antibody added as the detection antibody and test zones for determining the presence of said drugs or metabolites thereof, said test zones having immobilized thereon antigens that specifically bind to said anti-drug or anti-drug metabolite antibodies;

(c) allowing said composite solution to incubate on said surface of said membrane for at least one minute wherein said anti-drug or anti-drug metabolite antibodies not bound in step (a) bind to said antigens immobilized in said test zones;

(d) applying to a finger of said test subject a coating of labelled antibody which specifically binds to said anti-drug or anti-drug metabolite antibodies and said anti-species antibody;

(e) pressing said finger of said test subject against said control and test zones on said surface of said membrane for 2-10 seconds to deposit labelled antibody onto said surface of said membrane wherein a fingerprint of said test subject is produced in said control zone and wherein said labelled antibody binds to said anti-drug or anti-drug metabolite antibodies bound in said test zones, the presence of said labelled antibody indicating the absence of said drugs or metabolites thereof in said body fluid and the absence of said labeled antibody indicating the presence of said drugs or metabolites thereof in said body fluid.

33. The method of claim 32 wherein said drugs are selected from the group consisting of opiates, barbiturates, antipsychotics, antidepressants, analgesics, sedatives, hypnotics, benzodiazepines, solvents, stimulants, hallucinogens and anabolic steroids.

34. The method of claim 32 wherein said anti-drug or anti-drug metabolite antibodies are mouse anti-drug or anti-drug metabolite antibodies.

35. The method of claim 32 wherein said labelled antibody is labelled goat anti-mouse antibody.

36. The method of claim 32 wherein said labelled antibody is labelled with colloidal gold.

37. The method of claim 32 wherein said labelled antibody is labelled with a fluorescent label.

38. The method of claim 32 wherein said body fluid is saliva.

39. The method of claim 32 wherein said body fluid is blood.

40. The method of claim 32 wherein said body fluid is urine.

41. The method of claim 32 wherein said anti-species antibody is mouse anti-goat antibody.

42. The method of claim 32 further comprising washing said surface of said membrane after step (c).

43. A method for positively identifying a test subject by producing a fingerprint of said test subject comprising the steps of:

(a) coating a finger of said test subject with labelled antibody which specifically binds to anti-species antibody immobilized on the surface of a membrane mounted on an absorbent pad of a test device; and

(b) pressing said finger of said test subject against said surface of said membrane having immobilized thereon said anti-species antibody which specifically binds to said labelled antibody and thereby contacting said labelled antibody with said anti-species antibody immobilized on said surface of said membrane to produce a fingerprint of said test subject on said surface of said membrane.